BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    LEGION Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSTARAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UNKNOWN DEPUY PINNACLE METAL LINER

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 17, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    ZENITH AAA ENDIOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·September 29, 2009

    TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·October 18, 2016

    TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE

    FDA Adverse Event
    Injury ·COOK INC·Product code FCG·October 27, 2016

    Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021

    Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 15, 2022

    Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

    Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022

    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022